NCT00131079

Brief Summary

The potential health gains from active lifestyles are very well-known and it is recommended that all adults dedicate at least 30 minutes to activities of at least moderate intensity at least five days a week. What is still not known is how to help sedentary people follow this recommendation, by means of brief interventions feasible in routine general practice. This multi-center study was designed to evaluate the effectiveness of a physical activity promotion program (called PEPAF) implemented in 56 general practices of the Spanish public primary health care system. The study will test the capacity of the program to increase the physical activity level, physical fitness and health related quality of life of sedentary people.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,317

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

March 21, 2018

Status Verified

October 1, 2007

First QC Date

August 16, 2005

Last Update Submit

March 19, 2018

Conditions

ExercisePhysical FitnessQuality of Life

Keywords

Primary Health CarePhysicians, FamilyFamily PracticeHealth PromotionRandomized Controlled TrialsMulticenter StudiesPhysical FitnessQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Physical activity level (7-day Physical Activity Recall [PAR])

    six months from the start of the intervention

Secondary Outcomes (2)

  • Cardiorespiratory fitness

    six months from the start of the intervention

  • Health related quality of life (SF-36)

    six months from the start of the intervention

Study Arms (2)

PEPAF

EXPERIMENTAL

General Practitioner's assessment of physical activity level and minimal advice in routine clinical practice supplemented by physical activity prescription to those who accepted an additional 15 minutes appointment.

Behavioral: Experimental Programme for Physical Activity Promotion

Control

ACTIVE COMPARATOR
Behavioral: Control

Interventions

Experimental Programme for Physical Activity PromotionBEHAVIORAL

General practitioner's (GP) physical activity (PA) assessment and advise using a web-based software that prompted open questions to elicit believes about benefits of PA, graphical information about risks of inactivity and examples of type sentences to provide medical advise. Educational materials summarizing benefits, risks and motivation. Prescription: 15 minutes educational session in which GP negotiated a goal, addressed possible barriers and anticipated solutions using web-based tools for lack of time, community resources, and health problems. Finally, they designed a 3-month PA activity plan that derived in a standardized printed prescription of frequency, duration, intensity and progression of a selected PA or exercise that included a self-monitoring log.

PEPAF
ControlBEHAVIORAL

Control general practitioners assessed physical activity and performed recruitment in a similar way but offered usual care

Control

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedentary people who visit the general practitioner for any reason (those who do not dedicate at least 30 minutes to activities of at least moderate intensity at least five days a week).

You may not qualify if:

  • Disorders of the cardiovascular system
  • Transplant recipients
  • Renal or hepatic failure
  • Severe chronic obstructive pulmonary disease
  • Severe mental disorders
  • Chronic and acute severe infections
  • Metabolic uncontrolled disorders
  • Restrictive pathology of muscles, bones and joints
  • Complicated pregnancy
  • Contact difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Grandes G, Sanchez A, Torcal J, Ortega Sanchez-Pinilla R, Lizarraga K, Serra J; Grupo PEPAF. [Protocol for the multi-centre evaluation of the Experimental Programme Promotion of Physical Activity (PEPAF)]. Aten Primaria. 2003 Nov 15;32(8):475-80. doi: 10.1016/s0212-6567(03)79318-4. Spanish.

    PMID: 14636505BACKGROUND

  • Hillsdon M, Foster C, Thorogood M. Interventions for promoting physical activity. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003180. doi: 10.1002/14651858.CD003180.pub2.

    PMID: 15674903BACKGROUND

  • Eden KB, Orleans CT, Mulrow CD, Pender NJ, Teutsch SM. Does counseling by clinicians improve physical activity? A summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2002 Aug 6;137(3):208-15. doi: 10.7326/0003-4819-137-3-200208060-00015.

    PMID: 12160371BACKGROUND

  • Lopez-de-Munain J, Torcal J, Lopez V, Garay J. Prevention in routine general practice: activity patterns and potential promoting factors. Prev Med. 2001 Jan;32(1):13-22. doi: 10.1006/pmed.2000.0777.

    PMID: 11162322BACKGROUND

  • U. S. Department of Health and Human Services. Physical Activity and Health: a report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, 1996.

    BACKGROUND

  • Grandes G, Cortada JM, Arrazola A, Laka JP. Predictors of long-term outcome of a smoking cessation programme in primary care. Br J Gen Pract. 2003 Feb;53(487):101-7.

    PMID: 12817354BACKGROUND

  • Grandes G, Cortada JM, Arrazola A. An evidence-based programme for smoking cessation: effectiveness in routine general practice. Br J Gen Pract. 2000 Oct;50(459):803-7.

    PMID: 11127170BACKGROUND

  • Grandes G, Sanchez A, Montoya I, Ortega Sanchez-Pinilla R, Torcal J; PEPAF Group. Two-year longitudinal analysis of a cluster randomized trial of physical activity promotion by general practitioners. PLoS One. 2011 Mar 29;6(3):e18363. doi: 10.1371/journal.pone.0018363.

    PMID: 21479243DERIVED

  • Grandes G, Sanchez A, Sanchez-Pinilla RO, Torcal J, Montoya I, Lizarraga K, Serra J; PEPAF Group. Effectiveness of physical activity advice and prescription by physicians in routine primary care: a cluster randomized trial. Arch Intern Med. 2009 Apr 13;169(7):694-701. doi: 10.1001/archinternmed.2009.23.

    PMID: 19364999DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Gonzalo Grandes, Dr.

    Primary Care Research Unit of Bizkaia (Basque Health Service)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 17, 2005

Study Start

October 1, 2003

Study Completion

March 1, 2006

Last Updated

March 21, 2018

Record last verified: 2007-10